Chronic Kidney Disease Requiring Chronic DialysisPhase 4NCT04585607
Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
A Phase 4 study testing A medium cut-off dialyzer (Theranova) will be used for HDx. and A synthetic high-flux dialyzer (Polyflux) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- A medium cut-off dialyzer (Theranova) will be used for HDx. and A synthetic high-flux dialyzer (Polyflux)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Oct 2020to 7 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On HD treatment over 6 months before study enrollment
- Aged over 18 years
- Able to give informed consent
Who cannot join
- Hemiplegia or paraplegia state
- Planned renal transplant or conversion to peritoneal dialysis within study period
- Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
- History of monoclonal gammopathy
- Life expectancy <12 months
- Pregnancy or breast feeding
- Receiving immunosuppressant medication
- Inability to complete study assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia
The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.
Read the detailed description
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.
- Being tested
- A medium cut-off dialyzer (Theranova) will be used for HDx., A synthetic high-flux dialyzer (Polyflux)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A medium cut-off dialyzer (Theranova) will be used for HDx.Device
A medium cut-off dialyzer used for HDx (Theranova) must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription.
HD with MCO dialyzer (Theranova 400®, Baxter) vs. high-flux dialyzer (eg. Polyflux H, Baxter)
A synthetic high-flux dialyzer (Polyflux)Device
A synthetic high-flux dialyzer (Polyflux) used for hemodialysis must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required.
| Study group | Role | What they receive |
|---|---|---|
| Expanded hemodialysis (HDx) | Experimental | HDx therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription Receives: Device: A medium cut-off dialyzer (Theranova) will be used for HDx. |
| Conventional hemodialysis | Active comparator | Conventional hemodialysis therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription Receives: Device: A synthetic high-flux dialyzer (Polyflux) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of sarcopenia
Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)
Measured: Changes in serum level of Myostatin and IGF-1 every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Oct 2020
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participant hospital currently has around 90 maintenance HD patients and it is possible to recruit 74 patients for this study. Study subjects will be randomized to each treatment arm using a random number table. As outlined in the proposal, it is estimated that we may experience up to 30% of drop out during the study.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeongcheon Park, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585607
- Sponsor's protocol ID
- 3-2020-0337
- Status last verified
- Aug 2023
- First submitted
- 28 Sep 2020
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia
- ClinicalTrials.gov ID
- NCT04585607
- Acronym / sponsor ID
- 3-2020-0337
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.
Detailed description
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participant hospital currently has around 90 maintenance HD patients and it is possible to recruit 74 patients for this study. Study subjects will be randomized to each treatment arm using a random number table. As outlined in the proposal, it is estimated that we may experience up to 30% of drop out during the study.
| Arm | Type | Receives |
|---|---|---|
| Expanded hemodialysis (HDx) | Experimental | Device: A medium cut-off dialyzer (Theranova) will be used for HDx.HDx therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription |
| Conventional hemodialysis | Active comparator | Device: A synthetic high-flux dialyzer (Polyflux)Conventional hemodialysis therapies be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- On HD treatment over 6 months before study enrollment
- Aged over 18 years
- Able to give informed consent
Key exclusion criteria (8 listed)
- Hemiplegia or paraplegia state
- Planned renal transplant or conversion to peritoneal dialysis within study period
- Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
- History of monoclonal gammopathy
- Life expectancy <12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A medium cut-off dialyzer (Theranova) will be used for HDx.A medium cut-off dialyzer used for HDx (Theranova) must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription. HD with MCO dialyzer (Theranova 400®, Baxter) vs. high-flux dialyzer (eg. Polyflux H, Baxter) | Device | Expanded hemodialysis (HDx) |
| A synthetic high-flux dialyzer (Polyflux)A synthetic high-flux dialyzer (Polyflux) used for hemodialysis must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. | Device | Conventional hemodialysis |
Primary outcome
Biomarkers of sarcopenia
Time frame: Changes in serum level of Myostatin and IGF-1 every 6 months
Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A medium cut-off dialyzer (Theranova) will be used for HDx. and A synthetic high-flux dialyzer (Polyflux) in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of sarcopenia (time frame: Changes in serum level of Myostatin and IGF-1 every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.